Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00326482
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-15
First Post:
2006-05-16
Brief Title:
Liver Fibrosis in HIV-Infected Patients With Elevated Liver Enzymes on Antiretroviral Therapy
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Pilot Study of Hepatic Fibrosis in HIVAIDS Patients With Chronically Elevated Transaminases on Antiretroviral Therapy
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will provide a basis for research on the impact of liver injury caused by antiretroviral therapy in HIV-infected patients Elevated liver enzymes called AST and ALT are common in HIV-infected patients taking antiretroviral medications and can indicate liver damage Although there are a number of possible causes for these elevations such as infections with a hepatitis virus antiretroviral medications alone can lead to the elevations The study will focus particularly on evidence of liver fibrosis which is a sign of progressive liver damage
HIV-infected patients 18 and older who 1 have been taking combination antiretroviral therapy for at least 12 months and have been on a stable regimen for at least 3 months and 2 have had elevated AST or ALT levels for at least 6 months may be eligible for this study Patients who have had liver biopsies performed in the past may be eligible for participation
Participants undergo the following tests and procedures over a 12-month period
Oral glucose tolerance test The patient drinks a glucose sugar drink Blood samples are then drawn over 2 hours through an intravenous IV line in the patients arm This test measures how high the patients blood sugar and insulin levels rise after drinking a standard glucose load
Transient elastography This ultrasound test uses vibration sound waves to measure liver stiffness fibrosis Vibrations move faster through a fibrotic liver
Triple-phase CT scan and single slice CT scan of L4-5 Patients fast for 4 hours before the CT scan A contrast material is injected through a catheter placed in an arm vein to improve the visibility of the liver in the specialized X-ray images obtained in the CT scanner
Liver biopsy This test removes a small sample of liver tissue for microscopic examination particularly for evidence of fibrosis The skin over the biopsy site is numbed and a needle is passed through the skin and rapidly in and out of the liver Patients may be given a sedative for the procedure
Follow-up visits Patients return for follow-up visits 1 to 4 weeks after the liver biopsy and three more times over the course of the study for a medical history physical examination and blood tests
Patients may participate in an additional 4-year follow-up during which they have visits every 3-12 months and are offered the opportunity to repeat the biopsy no sooner than 1 year after the first biopsy
HIV-infected patients 18 and older who 1 have been taking combination antiretroviral therapy for at least 12 months and have been on a stable regimen for at least 3 months and 2 have had elevated AST or ALT levels for at least 6 months may be eligible for this study Patients who have had liver biopsies performed in the past may be eligible for participation
Participants undergo the following tests and procedures over a 12-month period
Oral glucose tolerance test The patient drinks a glucose sugar drink Blood samples are then drawn over 2 hours through an intravenous IV line in the patients arm This test measures how high the patients blood sugar and insulin levels rise after drinking a standard glucose load
Transient elastography This ultrasound test uses vibration sound waves to measure liver stiffness fibrosis Vibrations move faster through a fibrotic liver
Triple-phase CT scan and single slice CT scan of L4-5 Patients fast for 4 hours before the CT scan A contrast material is injected through a catheter placed in an arm vein to improve the visibility of the liver in the specialized X-ray images obtained in the CT scanner
Liver biopsy This test removes a small sample of liver tissue for microscopic examination particularly for evidence of fibrosis The skin over the biopsy site is numbed and a needle is passed through the skin and rapidly in and out of the liver Patients may be given a sedative for the procedure
Follow-up visits Patients return for follow-up visits 1 to 4 weeks after the liver biopsy and three more times over the course of the study for a medical history physical examination and blood tests
Patients may participate in an additional 4-year follow-up during which they have visits every 3-12 months and are offered the opportunity to repeat the biopsy no sooner than 1 year after the first biopsy
Detailed Description:
At present there are no clear guidelines as to when antiretroviral therapy for human immunodeficiency virus HIV infection should be stopped in the setting of elevated liver enzymes In large part this is due to a limited understanding of the natural history of antiretroviral-related hepatotoxicity Although several antiretrovirals have been reported to cause fatal acute hepatitis more often they cause an asymptomatic elevation in transaminase levels the optimal management of which is uncertain This pilot study seeks to create a foundation for research on the impact of antiretroviral-induced liver injury by providing an estimate of the prevalence of hepatic fibrosis in a cohort of sixty HIV-infected patients who have chronically elevated transaminases while on antiretroviral therapy in the absence of chronic hepatitis B HBV or C HCV coinfection Liver biopsy specimens will be evaluated for fibrosis by microscopic examination the current gold standard for assessing the nature and severity of liver disease1 The presence of fibrosis as well as other histopathology will be described using a validated scoring system Primarily this will be a crosssectional study but subjects will be offered the opportunity to participate in an extended follow-up period and undergo another liver biopsy Individuals will not be excluded on the basis of alcohol abuse insulin resistance or lipodystrophy but data will be collected on these potentially confounding variables Noninvasive measures such as transient elastography an ultrasonic technique will be assessed for their ability to predict fibrosis in this population Correlations will also be sought with laboratory markers of fibrosis The identification of fibrosis and its precursors in association with antiretroviral therapy may be very clinically relevant as it may slowly regress with cessation of the causal agents If the causal agent is continued however cirrhosis may develop the reversal of which is thought to be rare
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 06-I-0153 | None | None | None |